Peanut allergy study

Phase 1

Active, not recruiting

Conditions: Peanut Allergy
MedDRA version: 20.1Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2017-001334-26-IT

Lead Sponsor: AIMMUNE THERAPEUTICS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 1100

Inclusion Criteria

Subjects must meet all the following criteria to be eligible:
1. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future
clinical study that identifies ARC008 as a follow-on study option in the protocol
2. Written informed consent from the subject or guardian/parent (or both parents where required by local authorities) in accordance with local institutional review board (IRB)/ethics committee (EC) guidelines
3. Written assent from the subject as required by local IRB/EC guidelines
4. Use of effective birth control by sexually active females of childbearing potential (Section 5.9.4)
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following criteria are not eligible:
1. Did not complete a minimum of 3 months of AR101 Maintenance in the parent study if subject was assigned to AR101 in that study, except for
subjects in ARC004 who did not tolerate the nondaily AR101 dosing regimen, subjects in ARC007, or unless specified otherwise in the parent study
2. For subjects treated with AR101 in the parent study requiring a food challenge, failure to successfully consume at least the 300 mg single dose (443 mg cumulative dose) of peanut protein at parent study's exit food challenge
3. History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or
requiring a change in chronic therapeutic regimen, including malignancies occurring within 5 years prior to Screening and clinically active autoimmune diseases
4. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
5. Developed a clinically significant change in health status during the parent study that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
6. Taking a prohibited medication, as listed in Section 5.9.5
7. Currently participating in any other interventional clinical study other than the Aimmune parent study
8. Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or
unless allowed in the parent study
9. Subject is living in the same household or is a dependent of sponsor employees and/or site staff involved in conducting this study, except for
subjects originating from Aimmune Studies ARC002, ARC004, ARC007, ARC010, and ARC011
10. Currently in the build-up phase of immunotherapy for any non-food allergen
11. Hypersensitivity to epinephrine or hypersensitivity to any of the excipients in the IP
12. Pregnant or breastfeeding
13. Inability to withhold antihistamines for 5 half-lives prior to the initial day of escalation or visits at which an SPT or OLFC is conducted
14. Discontinued early from the parent study for any safety reason (other than a subject from study ARC004 who has experienced a lack of tolerance for a nondaily dosing regimen)
15. Any other condition that, in the opinion of the investigator, precludes participation for reasons of safety
16. Subjects unable to follow the protocol requirements